Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Ayal A. Aizer, MD
Study ID
NCT07130786
Phase
PHASE2
Status
Recruiting

Conditions

  • Brain Metastases From Extra-cranial Solid Tumors
  • Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
  • Brain Metastases, Adult
  • Primary Motor Cortex
  • Seizures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Levetiracetam (Keppra) — DRUG
    Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy

Study Details

This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.

Key Dates

Start date
Dec 23, 2025
Status verified
Mar 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prophylactic Levetiracetam
    Levetiracetam Anti-Seizure Medication
  • No Intervention: No Prophylactic Levetiracetam
    No Anti-Seizure Medication

Primary Outcome Measure

Seizure Rate [ Time Frame: Duration of time on study (estimated 1 year) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Ayal A Aizer, MD, MHS
(617) 732-7560

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